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Sr. Specialist, Document & Clinical Systems at Neurocrine Biosciences - ApplyBlast

Sr. Specialist, Document & Clinical Systems

Neurocrine Biosciences

4 months ago

3.7 on Glassdoor

San Diego, CA

Onsite

Full Time

Senior

0 applicants

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About this role

This role provides strategic support to Clinical Operations Study Teams by ensuring the quality, compliance, and inspection-readiness of Trial Master Files (TMFs). The employee will serve as a subject matter expert for electronic TMF systems, managing user access, training, and system releases while facilitating audit responses. Collaboration with stakeholders is key to maintaining industry standards and preparing for clinical trial documentation reviews.

Responsibilities

Lead monthly electronic Trial Master File meetings for the Clinical Operations team
Administer clinical systems by managing user access, training, and system releases
Prepare for and facilitate response to internal or external audits and inspections
Develop and update Trial Master File Standard Operating Procedures and work instructions
Generate monthly dashboards and reports on clinical trial documentation accuracy and timeliness

Skills

Qualifications

BS/BA degree in life scienceRN licenseMaster's degree in life science

About Neurocrine Biosciences

neurocrine.com

Headquarters

San Diego, California, United States

Company Size

1001-5000 employees

Founded

1992

View Profile

Neurocrine Biosciences is a biopharmaceutical company focused on discovering and developing treatments for patients with neurological, psychiatric, endocrine, and immunological disorders. With over 30 years of research, the company works to bring hope to people living with rare diseases and conditions that lack viable treatment options. Neurocrine develops and markets approved medicines while maintaining an active clinical pipeline across multiple therapeutic areas.